Efficacy and Enlightenment: LSD Psychotherapy and the Drug Amendments of 1962
Journal of the History of Medicine and Allied Sciences, 2012, Volume 69, Number 2, 221-250.
The decline in therapeutic research with lysergic acid diethylamide (LSD) in the United States over the course of the 1960s has commonly been attributed to the growing controversy surrounding its recreational use. However, research difficulties played an equal role in LSD psychotherapy’s demise, as they frustrated researchers’ efforts to clearly establish the efficacy of treatment. Once the Kefauver Harris Drug Amendments of 1962 introduced the requirement that proof of efficacy be established through controlled clinical trials before a drug could be approved to market, the value of clinical research became increasingly dependent on the scientific rigor of the trial’s design. LSD psychotherapy’s complex method of utilizing drug effects to catalyze a psychological treatment clashed with the controlled trial methodology on both theoretical and practical levels, making proof of efficacy difficult to obtain. Through a close examination of clinical trials performed after 1962, this article explores howthe newemphasis on controlled clinical trials frustrated the progress of LSD psychotherapy research by focusing researchers’ attention on trial design to the detriment of their therapeutic method. This analysis provides a new perspective on the death of LSD psychotherapy and explores the implications of the Drug Amendments of 1962.
KEYWORDS : LSD, controlled clinical trial, psychiatry, psychotherapy, psychopharmacology, Drug
Amendments of 1962, efficacy, drug regulation.
THE fate of lysergic acid diethylamide (LSD) research in the 1960s has typically been linked to controversy. LSD entered the United States in 1949 and immediately became a drug of great interest to psychiatrists. Therapeutic research with LSD flourished, with psychiatrists using it to promote more effective psychotherapy, or exploring how the powerful mystical, or psychedelic, LSD experience could transform aspects of personality and behavior in patients, including leading to sobriety in alcoholics. However, in the 1960s, public controversy over LSD’s increasing recreational use grew to fever pitch. Most accounts of LSD psychotherapy’s history have argued that this uproar doomed legitimate research by tarnishing the drug’s reputation, discouraging researchers from using it, and criminalizing the use of the drug, making it harder to gain approval for research.1 Alternatively, Steven Novak has argued that prior to the LSD abuse scandal, concern over LSD’s dangers, resulting from the irresponsible use of the drug by several researchers in Southern California, had already led to a government “crackdown” on LSD.2
The LSD controversies certainly did have a major impact on research. In 1966, they resulted in Sandoz Pharmaceuticals withdrawing its sponsorship of LSD investigations.3 Consequently, LSD’s development into a marketable pharmaceutical became much less likely, as researchers were not normally responsible for pushing drugs through the Food and Drug Administration’s (FDA) New Drug Application process without the sponsorship of a pharmaceutical company. Historians have also pointed to the experiences of individual researchers who cited the controversy, and subsequent difficulties in obtaining grants and supplies of LSD, to explain their withdrawal from the field.4 However, these hurdles did not end LSD psychotherapy research, which survived the controversies of the 1960s, before finally coming to a close in the early 1970s. LSD’s criminalization did not prohibit research and, until 1970, permission to conduct clinical research with LSD was obtained through the same process as any other drug.5 Additionally, many drugs, such as morphine, maintained dual lives as illegal street drugs, and valuable and legitimate tools of medicine. Indeed, a similar public, medical, and political outcry over the dangers of medical and non-medical abuse of amphetamines occurred concurrent with the LSD controversies of the mid to late 1960s. Amphetamine abuse was a target of the same prohibiting legislation as LSD, yet the drug retained a legitimate medical use.6
If controversy cannot completely explain the downfall of LSD psychotherapy, more attention needs to be paid to the later years of clinical research. Analyzing these trials reveals that the primary point of contention amongst researchers was LSD psychotherapy’s efficacy. A central question in the history of LSD therefore becomes, why, after more than twenty years of research, had a consensus on LSD psychotherapy’s efficacy not been reached? Answering this question requires contextualizing LSD research within the major changes in the regulation and practice of pharmaceutical research and development that occurred in the period, represented and regulated by the 1962 Kefauver Harris
Amendments to the federal Food, Drug and Cosmetic Act (referred to hereafter as the Drug Amendments of 1962). Doing so not only provides a more nuanced perspective on the downfall of LSD psychotherapy research, but also explores the significance of those amendments.